Instructions for New IRB Continuing Review (Progress) Report

1. Instructions for New IRB Continuing Review (Progress) Report

2. Demographics – Sections A & BProject & Recruitment Status Section A. Status Indicate whether the project is currently active and needs to be continued, or if IRB review can be terminated Section B. Recruitment Status If you are requesting continuation, then indicate whether or not subjects will be recruited in the coming project year.

3. Section CResearch Description Section C. Research Description Nature and Purpose of Proposed Studies • Technical Abstract: The technical abstract is directed towards scientists and provides a technical description of the proposed project. The scientific abstract from a grant application can be inserted here. • Summarize the study as it is currently being conducted and include a brief description of any substantive changes that have been made since the initial approval (e.g. changes to study design, procedures, recruitment methods, changes in Principal Investigator/Principal Researcher, etc). Non-substantive changes such as editorial changes, personnel changes (other than PI or PR), etc. should not be included in the summary. • indicate how the PI is affiliated with Lifespan • verify that all personnel have completed the mandatory annual training in HIPAA Privacy and Security (Lifespan requirement for all personnel)

4. Sections D & EProject Demographics and Subject Recruitment Section D. Project Demographics • Indicate if any specially protected populations are included in this research • Pediatric risk category is assigned at the time of initial review. If you are unsure as to the category for your research, look on the initial approval letter for the project. • Indicate how this project is supported Section E. Subject Recruitment • Questions 1-5 should be answered for the last project year (since initial or last continuing review) • The number of subjects enrolled should equal the number asked minus the number who declined. • Explain whether or not any subjects withdrew before completing the study and the reasons why

5. Section FRisk Determination Section F. Risk Determination • Minimal risk means that the likelihood of harm or discomfort caused by the research is not greater than what is normally experienced in daily life or during the performance of routine physical or psychological examinations or tests. • The Lifespan IRBs require all studies that present greater than minimal risk to include a plan (DSMP) for monitoring subject safety. Please note: a safety plan should not be confused with a DSMB (data safety monitoring board).All studies (greater than minimal risk) require a safety plan, but only some will require a DSMB.Acceptable plans for monitoring subject safety include a description as to how adverse events are evaluated across all performance sites with respect to subject risk and frequently include criteria that would be used to prematurely stop the trial for safety reasons. A description as to how the researchers will submit AE reports to the sponsor is not a safety monitoring plan. The IRB needs to know who will look at these reports as they flow in from multiple sites and how often the reports will be reviewed. Additional guidance is located on the IRB webpage at http://www.lifespan.org/research/irb/irbdatamonitoring.asp

6. Sections G & HUnanticipated Problem and AE & Gender and Minority Inclusion Section G. Unanticipated Problems and Adverse Events • We will no longer provide a list of local adverse events submitted to the IRB • Provide a summary of any unanticipated problems that may have increased risk to subjects or others. DSMB reports may be substituted in place of a summary of adverse events. • Please Note: question 3 asks about sponsor/FDA Safety Warnings/Alerts. This does not refer to routine adverse event reports. An example of a safety warning would be if the FDA or the sponsor released new information about a previously unknown, significant side effect which requires notification to subjects who took the drug. Section H. Gender and Minority Inclusion • The IRB must determine if subject selection and recruitment for this study is equitable. For studies with enrolment criteria that are based upon gender, race or ethnic groups, you must provide a breakdown of the subjects enrolled.

7. Section IJustification for Continuation Section I. Justification for Continuation • This section must be completed, signed and dated by the Principal Investigator. • Describe the progress made in your study. • Describe any new information that relates to the study • Justify your reasons for continuation or termination of the study.

8. Submission Instructions Submission Instructions • Sign the original report • Do not staple • Include all applicable attachments noted on the checklist at the end of the progress report form • Provide one single sided copy of the completed progress report form and all attachments

9. Attachments • Personnel list, list all personnel who will interact with human subjects or their identifiable data/specimens • Stamped copies of the currently approved consent forms (required for studies that use written informed consent). • Stamped copies of currently approved ads or recruitment materials • Clean copies of the proposed consent forms (required for studies that will use written informed consent). Make sure that the consent form follows the most recent IRB approved template • Clean copies of any ads or recruitment materials that will be used • HIPAA forms as applicable. A request for Review Preparatory to Research is required if you will look at identifiable data before subjects agree to participate. A Waiver of Authorization is required if you will record identifiable information without permission from research subjects. • Protocol, attach the complete protocol/grant application/research plan. For grant applications be sure to attach the ENTIRE grant (every page) • Investigator Brochure, required for studies that include the use of investigational drugs

10. Questions? If you have any questions, please call • Dawn Roux at 444-7547 for RIH IRB #1, • Adrienne McParlin at 444-3527 for RIH IRB #2 and TMH IRB, • Jacqui Poore at 444-2093 • Pat Houser at 444-2099 • Deb Temple at 444-5843